Amincewar FDA don Sabon Magani na ADHD a cikin Manya

Supernus Pharmaceuticals, Inc. ya sanar da cewa Hukumar Kula da Abinci da Magunguna ta Amurka (FDA) ta amince da faɗaɗa nuni ga Qelbree (viloxazine extended-release capsules) don maganin rashin kulawa da rashin ƙarfi (ADHD) a cikin manya marasa lafiya masu shekaru 18 da haihuwa. FDA yanzu ta amince da Qelbree don maganin ADHD a cikin yara (farawa daga shekaru 6), matasa da manya.

Kimanin yara miliyan 16, matasa, da manya suna da ADHD a cikin Amurka Yayin da yawancin yara da ADHD suka fi girma, har zuwa 90% na waɗanda aka gano tare da ADHD a lokacin ƙuruciyar suna ci gaba da samun ADHD a matsayin manya.

"Har yau, zaɓuɓɓukan ADHD marasa ƙarfi ga manya suna da iyaka sosai," in ji Greg Mattingly, MD, abokin kafa na St. Charles Psychiatric Associates a St. Louis, Mo. "Wannan amincewar labarai ce mai kyau kuma tana ba da sabon zaɓi na sabon labari don miliyoyin manya na Amurka waɗanda ke ƙoƙarin nemo madaidaicin magani don sarrafa alamun ADHD.

Qelbree labari ne mara kuzari da ake ɗauka sau ɗaya a rana don bayyanar da cikakken rana. An lura da inganci da haɓakar alamun da wuri a cikin jiyya. Yana da ingantaccen bayanin martaba da aminci, ba tare da wata shaida na yuwuwar cin zarafi ba a cikin karatun asibiti. Amincewar ta dogara ne akan ingantattun sakamako daga bazuwar, makafi biyu, nazarin wuribo-sarrafawa Mataki na III na Qelbree a cikin manya tare da ADHD kuma yana wakiltar amincewar farko na wani sabon magani mara kuzari ga manya a cikin shekaru 20.

"A matsayinmu na jagora a fagen CNS, mun himmatu sosai don fahimtar yadda ake magance hadaddun cututtuka irin su ADHD," in ji Jack Khattar, Shugaba da Shugaba na Supernus Pharmaceuticals. “Yin amincewar yau yana nuna babban ci gaba a cikin maganin ADHD kuma muhimmin ci gaba ne kawai shekara ɗaya bayan amincewar Qelbree don kula da marasa lafiya na yara. Muna alfaharin kawo sabon sabon zaɓi mara kuzari ga manya cikin kasuwa bayan shekaru ashirin."

A matsakaici-kashi na yau da kullun tsakanin 200mg zuwa 600mg, gwaji na Mataki na III ya sadu da ƙarshen ƙarshen farko wanda ke nuna raguwar canji daga tushe na Adult ADHD Investigator Symptom Rating Scale (AISRS) jimlar maki a ƙarshen binciken ya kasance babba a cikin manya. ana bi da su tare da Qelbree da placebo (p=0.0040). Muhimmiyar ci gaba a cikin ƙananan ma'auni na AISRS na rashin kulawa da hyperactivity / alamun rashin ƙarfi an kuma lura da su a cikin binciken. Haka kuma, binciken ya tsallaka mahimman kayan aiki na sakandare tare da mahimmancin ƙididdiga (p = 0.0023) a cikin canjin yanayin asibiti - an yarda da sikelin rashin lafiya. Da fatan za a duba ƙarin Muhimmin Bayanan Tsaro wanda aka haɗa a ƙasa.

An yi nazarin 1 Qelbree a cikin gwaji na asibiti 4. A cikin binciken daya na yara 6 zuwa 11 shekaru, raguwar alamun alamun ADHD sun kasance masu mahimmanci ga 100 MG da 200 MG allurai, farawa a mako 1. A cikin nazarin matasa 12 zuwa 17 shekaru, ADHD alamun raguwa sun kasance a kididdiga. mahimmanci ga 400 MG, farawa a mako na 2. A cikin bincike mai sassaucin ra'ayi na manya 18 zuwa 65 shekaru, raguwar alamar alamar ADHD sun kasance masu mahimmanci a cikin marasa lafiya na Qelbree, farawa a mako 2.

MUHIMMAN BAYANI AKAN KIYAYYA

Qelbree na iya ƙara tunanin kashe kansa da ayyuka, a cikin yara da manya tare da ADHD, musamman a cikin 'yan watannin farko na jiyya ko lokacin da aka canza kashi. Faɗa wa likitan ku idan kuna da (ko kuma idan akwai tarihin iyali na) tunanin kisan kai ko ayyuka kafin fara Qelbree. Kula da yanayin ku, ɗabi'unku, tunaninku, da ji yayin jiyya tare da Qelbree. Bayar da rahoton kowane sabon ko canje-canje kwatsam a cikin waɗannan alamun nan take. Kada majinyatan da su ma su sha wasu magungunan rage damuwa su sha Qelbree, musamman wadanda ake kira monoamine oxidase inhibitor ko MAOI, ko wasu magungunan asma.